Low Back PainNCT03066674
Effect of the Hands- on McKenzie Program on Low Back Pain
A study testing McKenzie group in people with Low Back Pain, run by Imam Abdulrahman Bin Faisal University.
Trial summary
Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly related to disability. The McKenzie method is one of most popular treatment options for LBP. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- McKenzie group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients will be age from 18 to 60 years old, and have LBP with or without leg pain, lasting from seven weeks to 12 weeks or more. Additional criteria include recurrent LBP, demonstrating a DP during the mechanical assessment , The subjects have a BMI of normal (17 to 23.9) or overweight (24 to 28.9). Patient is Eligible.
Who cannot join
- Participants who are underweight (BMI < 18.5) or obese (BMI ≥ 30) will be excluded . Those with contraindications to physical exercise according to the guidelines of the American College of Sports Medicine , such as those with serious spinal pathologies (fractures, tumours, and inflammatory diseases, such as ankylosing spondylitis), nerve root compromise (e.g., cauda equine syndrome), severe cardiopulmonary diseases,SCD, or pregnancy will be excluded.
- -
About this study
Official title: Effect of the Hands- on McKenzie Program on Derangement Syndrome in Sub-acute and Chronic Low Back Pain
Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly related to disability. The McKenzie method is one of most popular treatment options for LBP.
The objectives of this study are to determine the effect of the hands-on McKenzie program on pain, disability, spine mobility, and posture deviations in subjects with derangement low back pain.
Read the detailed description
Thirty eight patients with sub-acute and chronic LBP will be randomly assigned to the McKenzie group (MG) or the control group (CG). The MG will perform exercises with the hands-on procedure (three sessions per week) for two weeks, while the CG will perform only exercises for two weeks. Both groups will do a home exercise program. The outcome assessments will measure pain by the Pain Numerical Rating Scale (NPRS), the level of disability through the Oswestry Disability Index (ODI), spine mobility by range of motion (ROM) for the lumbar spine, and the centralization of symptoms and the postural alternation by postural analysis grid (PAG). By using SPSS version 20, a paired t-test will be use to study the effect of the McKenzie program before and after treatment. An independent t-test will be used to study the significance between the two groups.
- Conditions
- Low Back Pain
- Being tested
- McKenzie group, Control group
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McKenzie groupOther
Mobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program.
Control groupOther
Also called without any Hand -on Technique.
TENS,Exercises,Postural education ,Home exercises program.
| Study group | Role | What they receive |
|---|---|---|
| McKenzie group | Experimental | This group will receive Hand-on technique on the lumbar spine. Receives: Other: McKenzie group |
| Control group | Experimental | The Group will not receive Hand-on technique on the lumbar spine. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numerical Rating Scale (PNRS).
For assessing the pain in the low back.
Measured: Two weeks
Secondary outcomes (4)
Spine mobility
In the flexion/extension/rotation and side bending(Right -Left)
Measured: Two weeks
Centralization or non-centralizer (Peripheralization) of patient symptoms.
Using the body chart.
Measured: Two weeks.
Postural alterations.
It is measure by Postural Analysis Grid (PAG) and software
Measured: Two weeks
Disability associated with LBP
It is measure by The Oswestry Disability Index (ODI)
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Jan 2016
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina Abdullah AL-Banawi, Imam Abdulrahman Bin Faisal University
- Investigators
- LINA A ALBANAWI, MASTER, Study chair, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066674
- Sponsor's protocol ID
- 2015-03-178
- Status last verified
- Aug 2017
- First submitted
- 23 Feb 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Hands- on McKenzie Program on Derangement Syndrome in Sub-acute and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03066674
- Acronym / sponsor ID
- 2015-03-178
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly related to disability. The McKenzie method is one of most popular treatment options for LBP.
The objectives of this study are to determine the effect of the hands-on McKenzie program on pain, disability, spine mobility, and posture deviations in subjects with derangement low back pain.
Detailed description
Thirty eight patients with sub-acute and chronic LBP will be randomly assigned to the McKenzie group (MG) or the control group (CG). The MG will perform exercises with the hands-on procedure (three sessions per week) for two weeks, while the CG will perform only exercises for two weeks. Both groups will do a home exercise program. The outcome assessments will measure pain by the Pain Numerical Rating Scale (NPRS), the level of disability through the Oswestry Disability Index (ODI), spine mobility by range of motion (ROM) for the lumbar spine, and the centralization of symptoms and the postural alternation by postural analysis grid (PAG). By using SPSS version 20, a paired t-test will be use to study the effect of the McKenzie program before and after treatment. An independent t-test will be used to study the significance between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| McKenzie group | Experimental | Other: McKenzie groupThis group will receive Hand-on technique on the lumbar spine. |
| Control group | Experimental | Other: Control groupThe Group will not receive Hand-on technique on the lumbar spine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patients will be age from 18 to 60 years old, and have LBP with or without leg pain, lasting from seven weeks to 12 weeks or more. Additional criteria include recurrent LBP, demonstrating a DP during the mechanical assessment , The subjects have a BMI of normal (17 to 23.9) or overweight (24 to 28.9). Patient is Eligible.
Key exclusion criteria (2 listed)
- Participants who are underweight (BMI < 18.5) or obese (BMI ≥ 30) will be excluded . Those with contraindications to physical exercise according to the guidelines of the American College of Sports Medicine , such as those with serious spinal pathologies (fractures, tumours, and inflammatory diseases, such as ankylosing spondylitis), nerve root compromise (e.g., cauda equine syndrome), severe cardiopulmonary diseases,SCD, or pregnancy will be excluded.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McKenzie groupMobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program. | Other | McKenzie group |
| Control groupAlso: without any Hand -on Technique.TENS,Exercises,Postural education ,Home exercises program. | Other | Control group |
Primary outcome
Pain Numerical Rating Scale (PNRS).
Time frame: Two weeks
For assessing the pain in the low back.
4 secondary outcomes
Spine mobility
Time frame: Two weeks
Centralization or non-centralizer (Peripheralization) of patient symptoms.
Time frame: Two weeks.
Postural alterations.
Time frame: Two weeks
Disability associated with LBP
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Low Back Pain
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McGill Stabilization Exercises Versus Pilates for Chronic Low Back Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LINA A ALBANAWI, MASTER study chair
Imam Abdulrahman Bin Faisal University
Questions about this trial
What is this clinical trial studying?
A study testing McKenzie group in people with Low Back Pain, run by Imam Abdulrahman Bin Faisal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Scale (PNRS). (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.